Placement tools for body cavity drainage devices and related methods

ABSTRACT

A body cavity drainage device placement tool for placing a body cavity drainage tube at least partially within a body cavity of a patient. The body cavity drainage device includes a shaft, a handle attached to or integral with a proximal end of the shaft, and a distal end of the shaft sized and configured for insertion through a lateral opening of the body cavity drainage tube and at least partially through a central lumen of the body cavity drainage tube to proximate a distal end of the body cavity drainage tube. Methods relate to using a body cavity drainage device placement tool.

BACKGROUND

Field

Embodiments of the invention relate to body cavity drainage devices andrelated devices and methods.

State of the Art

Drainage devices, especially for the evacuation of a pleural cavity, mayconsist of a hollow, flexible tube inserted through an incision into thepleural cavity. The shape and configuration of the pleural cavity oftennecessitates multiple incisions to be made to permit the drainage tubeto reach various locations in the pleural cavity. The need for multipleincisions may generally result in an extended hospital stay for apatient suffering from a severe case of pleurisy.

BRIEF SUMMARY

In one embodiment of the disclosure, a body cavity drainage deviceplacement tool for placing a body cavity drainage tube at leastpartially within a body cavity of a patient includes a shaft, a handleattached to or integral with a proximal end of the shaft, and a distalend of the shaft sized and configured for insertion through a lateralopening of the body cavity drainage tube and at least partially througha central lumen of the body cavity drainage tube to proximate a distalend of the body cavity drainage tube.

In another embodiment of the disclosure, a method of inserting a bodycavity drainage device into a body cavity of a patient includesinserting a distal end of a shaft of a placement tool through a lateralopening in a body cavity drainage tube and into a central lumen of thebody cavity drainage tube, positioning the distal end of the shaft ofthe placement tool proximate a distal end of the body cavity drainagetube, inserting the body cavity drainage tube and placement tool throughan incision in the patient and into the body cavity of the patient, andremoving the placement tool from the body cavity drainage tube and bodycavity. The body cavity drainage tube may remain in the body cavity inits inserted position as the placement tool is removed from the bodycavity drainage tube.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 shows a top view of a drainage device according to an embodimentof the present disclosure;

FIG. 2 shows a side view of the drainage device of FIG. 1;

FIG. 3 shows a top cross-sectional view of the drainage device of FIG.1;

FIG. 4 shows a top cross-sectional view of the drainage device of FIG. 1in a bent position;

FIG. 5 shows an enlarged top view of an activation apparatus accordingto an embodiment of the present disclosure;

FIG. 6 shows a side cross-sectional view of the activation apparatus ofFIG. 5;

FIG. 7 shows a schematic side view of a drainage device according to anembodiment of the present disclosure;

FIG. 8 shows a side view of a drainage tube placement tool according toan embodiment of the present disclosure;

FIG. 9 shows a detail view of the drainage tube placement tool of FIG. 8disposed within a drainage tube;

FIG. 10 shows a cross-sectional detail view of the drainage tubeplacement tool of FIG. 8 disposed within a drainage tube;

FIG. 11 shows a side view of a drainage tube placement tool according toanother embodiment of the present disclosure;

FIG. 12 shows a side view of a cleaning device for a drainage tubeaccording to an embodiment of the present disclosure;

FIG. 13 shows a top view of a surgical kit including a drainage deviceand a drainage tube placement tool according to an embodiment of thepresent disclosure; and

FIG. 14 shows a cross-sectional view of a drainage device according toan embodiment of the present disclosure.

DETAILED DESCRIPTION

As used herein, the term “distal” relates to an end of a deviceconfigured to be inserted into the body cavity of a patient, and theterm “proximal” relates to an end of a device configured to be outsideof a patient.

In one embodiment of the present disclosure, a body cavity drainagedevice includes a body cavity drainage tube with a proximal end and adistal end. The proximal end of the body cavity drainage tube may beconnected to an activation apparatus including a rotatable controldevice and a compliant locking mechanism. Rotation of the rotatablecontrol device may cause the distal end of the body cavity drainage tubeto move relative to the proximal end of the drainage tube. In anunlocked position, the compliant locking mechanism may allow rotation ofthe rotatable control device. In a locked position, the compliantlocking mechanism may substantially prevent rotation of the rotatablecontrol device until a predetermined torque value is applied to therotatable control device.

In another embodiment of the present disclosure, a body cavity drainagedevice includes a body cavity drainage tube extending along a centralaxis between a proximal end and a distal end. A fluid outlet may beoriented substantially coaxially with the drainage tube. The proximalend of the body cavity drainage tube may be attached to an activationapparatus. The activation apparatus may include a rotatable controldevice for controlling a position of the distal end of the body cavitydrainage tube.

In yet another embodiment of the present disclosure, a body cavitydrainage device placement tool for use with a body cavity drainage tubeincludes a shaft, a handle at or near a proximal end of the shaft, and adistal end of the shaft for insertion through at least one lateralopening of the body cavity drainage tube and at least partially througha central lumen of the body cavity drainage tube for placement of thedistal end of the body cavity drainage tube in a body cavity of apatient.

In yet another embodiment of the present disclosure, a package includingat least three of a body cavity drainage device, a drainage tubeplacement tool, a drainage tube cleaning device, and a visualizationdevice may be provided to a user.

FIG. 1 shows a drainage device 100 according to an embodiment of thepresent disclosure. The drainage device 100 may include a drainage tube102 configured to provide drainage to a body cavity defined by orsurrounded by soft tissue. For example, the drainage device 100 may beused to withdraw infection exudates from a pleural cavity by applyingsuction to the drainage tube 102. In addition, positive pressure may beapplied to the drainage tube 102, such as to introduce a fluid into thedrainage tube 102 and/or body cavity, such as to dissolve material to beremoved or to dislodge flow restrictions within the drainage tube 102.

Although the drainage device 100 is described herein relative to usewith pleural cavities, the present disclosure is not so limited.Accordingly, the drainage device 100, elements thereof, and accompanyingelements described in the present disclosure may be used for drainagefrom or introduction of fluids into other body cavities such as, by wayof non-limiting example, veins, arteries, abdominal cavities, cranialcavities, etc.

The drainage tube 102 may include a proximal end 104 and a distal end106. The drainage tube 102 may include at least one of an axial opening108 in the distal end 106 and one or more lateral openings 110 proximatethe distal end 106 into an open lumen of the drainage tube 102. Thedrainage device 100 may be configured to inhibit damage to the softtissue surrounding the cavity while a portion of the drainage device 100is inserted into the cavity or moved about within the cavity. Forexample, the distal end 106 of the drainage device 100 may include asubstantially blunted geometry to prevent damage to the body cavity. Inother words, the distal end 106 may not have any sharp, pointed, orabrupt edges that, if present, could puncture or otherwise damage softtissue of a body cavity. In some embodiments, the drainage device 100may include any and all of the features and characteristics of thedrainage devices described in U.S. patent application Ser. No.13/840,986, filed Mar. 15, 2013 and published as US 2013/0211385, whichis incorporated herein by reference for all that it discloses.

In some embodiments, the axial opening 108 and the one or more lateralopenings 110 may have an average diameter that is substantially the samesize or smaller than an average inside diameter of the drainage tube102. Sizing the axial opening 108 and the one or more lateral openingsin this manner relative to the inside diameter of the drainage tube 102may ensure that any clots (e.g., blood clots) suctioned into thedrainage tube 102 are sufficiently small to pass through the drainagetube 102 without obstructing (e.g., clogging) the drainage tube 102.

The proximal end 104 of the drainage tube 102 may be coupled to anactivation apparatus 112 that may include a control device 114. Thecontrol device 114 may be, for example, a knob configured to be manuallymanipulated (e.g., rotated) by a user, such as a practitioner,physician, nurse, patient, or care provider.

FIG. 2 shows a side view of the drainage device 100 of FIG. 1. Thedrainage device 100 may include a fluid outlet 202 in fluidcommunication with the drainage tube 102 and may be configured forconnection to a vacuum source for removal of material from a body cavityor to a source of one or more treatments to be introduced into the bodycavity. In some embodiments, the fluid outlet 202 may be an integralextension of the drainage tube 102.

FIG. 3 shows a cross-sectional view of the drainage device 100 ofFIG. 1. An activation apparatus 112 may be attached at or near theproximal end 104 of the drainage tube 102. The activation apparatus 112may include a pinion gear 302, a first rack 304, and a second rack 306.The first and second racks 304, 306 may be complementary to and meshedwith the pinion gear 302. First and second flexible members 308, 310 maybe attached to the first and second racks 304 and 306, respectively. Thefirst and second flexible members 308, 310 may have an elongate shapeand may include, for example, metallic wires made from steel, titanium,nitinol, or other metals or alloys. Additionally or alternatively, thefirst and second flexible members 308, 310 may include synthetic ornatural fibers. As a further example, such wires or fibers may include asingle strand or multiple strands of one or more materials bundled orwoven together. The first and second flexible members 308, 310 may bedisposed within closed lumens within a wall 312 of the drainage tube102. The lumens through which the first and second flexible members 308,310 extend may not be in fluid communication with the open lumen definedby the drainage tube 102 or with an exterior of the drainage tube 102.In some embodiments, the flexible members 308, 310 may be completelylaterally enclosed within the wall 312 of the drainage tube 102. Thelumens may be positioned within the wall of the drainage tube 102 suchthat each of the flexible members 308, 310 is substantially directlyopposite the other across a diameter of the drainage tube 102.

FIG. 4 shows another cross-sectional view of the drainage device 100 ofFIG. 1. The pinion gear 302 may rotate in response to an applied torque402. As a non-limiting example, the torque 402 may be applied by a usermanually operating the control device 114 (FIG. 1), which may beconnected to the pinion gear 302. Other embodiments may include anautomated system configured to operate the control device 114. Rotationof the pinion gear 302 may cause generally linear movement of the firstrack 304 in a first direction 404 and a corresponding generally linearmovement of the second rack 306 in a second, opposite direction 406.Movement of the first rack 304 may create tension in the first flexiblemember 308, which imparts a compressive force to a first side 408 of thedrainage tube 102. Movement of the second rack 306 may allow slack inthe second flexible member 310. The compressive force from the firstflexible member 308 may cause the drainage tube 102 to contract alongthe first side 408 in which the first flexible member 308 is disposedand lengthen along a second side 410 in which the second flexible member310 is disposed, causing the drainage tube 102 to assume an arcuate(e.g., bent) shape, such as the shape shown in FIG. 4. The magnitude ofthe applied torque 402 and the corresponding refraction of the firstflexible member 308 may determine the extent of curvature imparted tothe drainage tube 102. Torque may be applied in a direction opposite thedirection indicated in FIG. 4, resulting in curvature of the drainagetube 102 in an opposite direction to the curvature shown. In someembodiments, the drainage device 100 may be configured such that thedistal end 106 may rotate at least about 360° from a first fully curvedposition (e.g., pointing down and to the left in the perspective shownin FIG. 4) to a second, opposite fully curved position (e.g., pointingdown and to the right from the same perspective).

In some embodiments, the drainage device 100 may include one or moreoptical fibers extending through lumens formed in the wall 312 of thedrainage tube 102 and terminating at or near the distal end 106. Suchoptical fibers may be connected to a visualization device (e.g., acamera providing an image to an electronic display) to assist a user inplacing or moving the drainage tube 102 within a patient's body cavity.

Referring now to FIG. 5, the activation apparatus 112 may include acompliant locking mechanism 500. The compliant locking mechanism 500 mayhave a locked position in which the compliant locking mechanism 500maintains the control device 114 in a predetermined position selected bya user. The user may release (e.g., place the compliant lockingmechanism 500 in an unlocked position) the compliant locking mechanism500 to facilitate rotation of the control device 114. In someembodiments, the compliant locking mechanism 500 may be configured toallow rotation of the control device 114 under a sufficiently highapplied torque 402 (FIG. 4) even when the compliant locking mechanism isin the locked position.

In some embodiments, the compliant locking mechanism 500 may include alock lever 502 with a proximal end 504 pivotably affixed to a mainhousing portion 506 of the activation apparatus 112. As shown in FIG. 5,the proximal end 504 of the lock lever 502 may be resiliently (e.g.,elastically) attached to the main housing portion 506. In someembodiments, the lock lever 502 may be integrally molded with the mainhousing portion 506 (e.g., by an injection molding process). In otherwords, the lock lever 502 may include a flexible structural portion(i.e., the resilient attachment of the proximal end 504 to the mainhousing portion 506) for rotating the lock lever 502 between the lockedand unlocked positions. In other embodiments, the lock lever 502 may beattached to the main housing portion 506 with, e.g., a pinned hinge, andmay be biased to a locked position by an elastic biasing element (e.g.,a spring).

A distal end 508 of the lock lever 502 may include serrations (e.g.,gear teeth) 510 configured to substantially mesh with gear teeth 512 ofthe pinion gear 302. In a locked position, the serrations 510 of thedistal end 508 of the lock lever 502 may mesh with the gear teeth 512 ofthe pinion gear 302 and inhibit rotation of the pinion gear 302 when atorque is not applied (or an insufficient torque is applied) to thecontrol device 114, thereby fixing the control device 114 at a desiredposition.

When a user desires to unlock the compliant locking mechanism 500, theuser may depress the lock lever 502 with a force 602, as shown in FIG.6. The lock lever 502 may pivot at the proximal end 504, and theserrations 510 (FIG. 5) of the distal end 508 may move downward (withreference to the orientation of FIG. 6) to clear (i.e., disengage from)the gear teeth 512 of the pinion gear 302 and facilitate rotation of thecontrol device 114 and pinion gear 302. The user may then rotate thecontrol device 114 to the desired position and release the lock lever502 to maintain the control device 114 in the selected position.

Alternatively, the user may leave the lock lever 502 in the lockedposition, and apply torque to the control device 114. At a sufficientlyhigh torque value, the lock lever 502 may elastically deform at one ormore locations, e.g., at an angled juncture 604. As torque is applied tothe control device 114, mechanical interaction between the serrations510 (FIG. 5) and the gear teeth 512 may force the distal end 508 of thelock lever 502 in direction 606, i.e., away from the pinion gear 302.Under a sufficiently high applied torque, the lock lever 502 mayelastically deform enough to enable the serrations 510 (FIG. 5) todisengage from the gear teeth 512 of the pinion gear 302 and allowrotation of the pinion gear 302 even when the lock lever 502 remains ina locked position (i.e., in the absence of force 602). Thus, thecompliant lock mechanism 500 may enable a user to adjust the position ofthe control device 114 without depressing the lock lever 502, whilemaintaining the position of the control device 114 in the absence of asufficiently high applied torque.

For example, the compliant lock mechanism 500 may be configured suchthat it avoids or reduces movement of the control device 114 resultingfrom incidental contact when in the locked position, but allows movementat a threshold level of applied torque. Such a level of applied torquemay be, by way of example and not limitation, a torque value of greaterthan about 0.5 lb·ft (0.68 N·m), greater than about 1.0 lb·ft (1.36N·m), or greater than about 5.0 lb·ft (6.8 N·m).

Accordingly, a method of draining fluid from a body cavity may includepositioning a distal end of a tube of a body cavity drainage device at afirst position within the body cavity. Fluid may be drained from thebody cavity through the distal end of the tube of the body cavitydrainage device while the distal end of the tube is in the firstposition. A user may depress a locking lever to unlock a rotatablecontrol device of the body cavity drainage device external to the bodycavity. The user may move the distal end of the tube of the body cavitydrainage device to a second, different position within the body cavity.Moving the distal end of the tube of the body cavity drainage device mayinclude rotating the rotatable control device of the body cavitydrainage device, and the rotatable control device may be coupled to thedistal end of the tube of the body cavity drainage device by flexiblemembers.

In some embodiments, a drainage device may include a fluid outlet thatis substantially aligned with the drainage tube. For example, referringnow to FIG. 7, a schematic side view of another embodiment of a drainagedevice 700 is shown. In this embodiment, a drainage tube 702 extendsalong a central axis A_(c), through an activation apparatus 704, and toa fluid outlet 706 also aligned along the central axis A_(c). In someembodiments, a single tube extending through the activation apparatus704 may form the drainage tube 702 and the fluid outlet 706. In otherwords, the drainage device 700 may comprise a unitary drainage tube 702with a distal end 708 for insertion into a body cavity of a patient, aproximal end 710 including a fluid outlet 706, and an activationapparatus 704 disposed on the drainage tube 702 between the proximal end710 and the distal end 708. In other embodiments, the drainage tube 702and the fluid outlet 706 may be two separate tubes coupled (e.g.,bonded, press-fit, glued) together.

In the embodiment of FIG. 7, a control device 714 may be disposed in aposition offset from a central axis A_(c) of the drainage tube 702. Atleast one flexible member 718, substantially as described above inconnection with FIGS. 3 and 4, may extend from the control device 714along an at least partially curvilinear (i.e., arcuate) path 720. The atleast one flexible member 718 may be constrained to the curvilinear path720 by guides 716 in the activation apparatus 704 and channels in thedrainage tube 702. The control device 714, the at least one flexiblemember 718, and the drainage tube 702 may function in a similar mannerto that described above in connection with FIGS. 3 and 4. The activationapparatus 704 may further include a compliant locking mechanism, asdescribed above in connection with FIGS. 5 and 6.

Referring now to FIG. 8, a side view of a drainage tube placement tool800 is shown. The drainage tube placement tool 800 may include a handle802 affixed to a shaft 804 at a proximal end 806. The shaft 804 may besubstantially straight, or may include a curved portion 810 near adistal end 808, as shown in FIG. 8. In some embodiments, the shaft 804may have a substantially circular cross-sectional shape. In otherembodiments, the shaft 804 may have a different cross-sectional shape,such as an elliptical shape, a rectilinear shape, or combinationsthereof.

The shaft 804 may include a shoulder 812 (e.g., a step) where thecross-sectional shape of the shaft 804 varies from a first diameter 814to a second, smaller diameter 816. As shown in FIG. 8, the shoulder 812may be disposed proximate the distal end 808 of the shaft 804. By way ofexample and not limitation, the shoulder 812 may be positioned withinabout one (1) inch (25.4 mm) or less of the distal end 808 of the shaft804. In other embodiments (e.g., as shown below in FIG. 10), theshoulder may be disposed proximate the handle portion 802, or thedrainage tube placement tool 800 may not include a shoulder.

Referring now to FIG. 9, a user may insert the shaft 804 of the drainagetube placement tool 800 through a lateral opening 910 of a drainage tube902. The lateral opening 910 may be similar to the lateral openings 110described in connection with FIGS. 1 and 2. In some embodiments, thelateral opening 910 may include features configured to facilitateinsertion of the drainage tube placement tool 800 within the drainagetube 902. For example, a slit 912 may extend from a periphery of thelateral opening 910 into a wall 914 of the drainage tube 902. Uponinsertion of the distal end 812 (FIG. 8) of the drainage tube placementtool 800 within the lateral opening 910, the slit 912 may at leastpartially open, as shown in FIG. 9, to ease passage of the drainage tubeplacement tool 800 through the drainage tube 902. Upon removal of thedrainage tube placement tool 800 from the drainage tube 902, the slit912 may substantially close, and the diameter of the lateral opening 910may be substantially similar to the diameter of other lateral openings916. Suction applied to the drainage tube 902 after removal of thedrainage tube placement tool 800 may also assist the slit 912 to close.In other embodiments, the diameter of the lateral opening 910 may begreater than the diameter of other lateral openings 110.

The drainage tube placement tool 800 may be configured to stop at apredetermined insertion distance within the drainage tube 902. Referringnow to FIG. 10, after the drainage tube placement tool 800 (FIG. 8) isinserted into the lateral opening 910 (FIG. 9) of the drainage tube 902,the user may continue to insert the drainage tube placement tool 800within the drainage tube 902 until the shoulder 812 of the shaft 804 ofthe drainage tube placement tool 800 abuts a ferrule 1000 disposed nearthe distal end 106 of the drainage tube 902 and the shoulder 812prevents further insertion of the placement tool 800 within the drainagetube 902. The portion of the shaft 804 having the second diameter 816(FIG. 8) may enter an axial opening 1002 of the ferrule 1000. In thisposition, the distal end 808 (FIG. 8) of the drainage tube placementtool 800 may be disposed proximate a distal end 1004 of the drainagetube 902. In some embodiments, the axial opening 1002 of the ferrule1000 may have a diameter smaller than an inside diameter of the drainagetube 102.

In some embodiments, the shaft 804 of the drainage tube placement tool800 may have a length sufficient to extend through the lateral opening910 of the body cavity drainage tube 902, through a central lumen of thebody cavity drainage tube 902, and position the distal end 808 of theshaft 804 past the distal end 1004 of the drainage tube 902. In otherwords, when the shaft 804 is inserted fully into the body cavitydrainage tube 902, the distal end 808 of the shaft 804 may protrudebeyond the distal end 1004 of the drainage tube 902.

In some embodiments, at least one of the flexible members 308, 310 (FIG.3) or 718 (FIG. 7) may be attached to the ferrule 1000. In other words,the ferrule 1000 may be coupled to a control device (e.g., controldevice 114 (FIG. 3) or control device 714 (FIG. 7)) of an activationapparatus (e.g., activation apparatus 112 (FIG. 3) or activationapparatus 704 (FIG. 7)) through one or more flexible members 308, 310,and 718.

The drainage tube placement tool 800 may contribute additional stiffness(i.e., rigidity) to the drainage tube 902 to enable a user to insert thedrainage tube 902 through an incision in a patient's body and into,e.g., the pleural cavity, without collapsing (e.g., kinking) thedrainage tube 902. In some embodiments, the drainage tube placement tool800 may be made from a material having a greater modulus of elasticity(i.e., a greater stiffness) than the material of the drainage tube 902.

In use, a user may insert the distal end 812 of the drainage tubeplacement tool 800 into the drainage tube 902, grasp the handle 802, andinsert the drainage tube 902 with the drainage tube placement tool 800disposed therein through an incision and into the body cavity. The usermay then remove the drainage tube placement tool 800 from the drainagetube 902, leaving at least a portion of the drainage tube 902 disposedwithin the body cavity.

The curved portion 810 of the drainage tube placement tool 800 may beshaped to ease insertion of the drainage tube 902 with the drainage tubeplacement tool 800 disposed therein within a body cavity of a particularconfiguration. For example, the curved portion 810 of the drainage tubeplacement tool 800 may have a shape of a desired path the drainage tube902 may follow as the drainage tube 902 is inserted into a body cavity.By way of another example, the curve may facilitate directing theplacement of the drainage tube 902 within the body cavity.

Referring now to FIG. 11, another embodiment of a drainage tubeplacement tool 1100 is shown. The drainage tube placement tool 1100 mayinclude a shaft 1104 with a shoulder 1102 disposed near a proximal end1106 of the shaft 1104. A distal end 1108 of the shaft 1104 may beinserted in a lateral opening 910, 916 (FIG. 9) of a drainage tube 902.The shoulder 1102 may abut a wall 914 (FIG. 9) of the drainage tube 902surrounding the lateral opening 910, 916 at a predetermined insertiondistance. In other embodiments, the shoulder 1102 may be absent, and ahandle 1110 may abut against the lateral opening 910, 916 to stopfurther insertion of the drainage tube placement tool 1100 into adrainage tube. Thus, the drainage tube placement tool 1100 may be usedwith a drainage tube device that does or does not include a ferrule 1000(FIG. 10). For example, the drainage tube placement tool 1100 may beused with a drainage device according to the present disclosure, e.g.,drainage devices 100, 700, or may be used with prior art drainagedevices. As shown in FIG. 11, the shaft 1104 of the drainage tubeplacement tool 1100 may be substantially straight. In other embodiments,the shaft 1104 of the drainage tube placement tool 1100 may include acurved portion 810 like that shown in the embodiment of FIG. 8.

In some embodiments, the shaft 804, 1104 of the drainage tube placementtool 800, 1100 may be hollow (e.g., may include a channel therethrough)to accommodate a guide wire for aiding placement of the drainage tubewithin a body cavity and/or to accommodate one or more optical fiberstherein. A guide wire may be placed in a desired location through ahollow needle, and one or more dilators may be threaded over the guidewire to expand an incision made by the hollow needle through the skinand/or other tissue. When the incision is sufficiently expanded, thedrainage tube placement tool 800, 1100 may be inserted into a drainagetube 100, 700 as described above, and the guide wire may be threadedthrough the drainage tube placement tool 800, 1100. A distal end of thedrainage tube 100, 700 may then be placed in the body cavity through theexpanded incision using the guide wire. In some embodiments, one or moreoptical fibers may be inserted through the channel of the drainage tubeplacement tool 800, 1100. The one or more optical fibers may beconnected to a visualization device (e.g., a camera in communicationwith an electronic display) to assist the user in placing a drainagetube 100, 700 within the body cavity.

FIG. 12 shows an embodiment of a cleaning device 1200 according to thepresent disclosure. The cleaning device 1200 may include a handle 1202,a shaft 1204, and a cleaning instrument 1206. The cleaning instrument1206 may be configured to be inserted through an fluid outlet 202, 704(FIGS. 2 and 7) of the drainage device 100, 700. In some embodiments,the cleaning instrument 1206 may be inserted into the drainage device100, 700 while a portion of the drainage tube 102 remains disposedwithin a body cavity. The cleaning instrument 1206 may be configured toretrieve solid matter, e.g., blood clots or other coagulations ofphysiological fluids, from the drainage tube 102. In use, a user mayremove a vacuum source from the fluid outlet 202, 704 of the drainagedevice 100, 700. The user may then insert the cleaning instrument 1206into the fluid outlet 202, 704, grasp the handle 1202, and feed thecleaning device 1200 into the drainage tube 102 until the cleaninginstrument 1206 contacts the solid matter. The user may remove thecleaning device 1200 and solid matter from the drainage tube 102 andreconnect the vacuum source to the fluid outlet 202, 704. In someembodiments, the cleaning instrument 1206 may comprise a coil ofresilient material, such as a metal alloy or a polymer. The cleaninginstrument 1206 may have a helical shape, which may be rotated withinthe drainage tube 102 to force the solid matter out of the drainage tube102.

Referring to FIG. 13, a surgical kit 1300 may include at least adrainage device 100, 700 and a drainage tube placement tool 800, 1100.Each of the drainage device 100, 700 and the drainage tube placementtool 800, 1100 in the surgical kit 1300 may be substantially asdescribed above. In some embodiments, the surgical kit 1300 may alsoinclude one or more of a cleaning device 1200 for removal ofobstructions in the drainage device 100, 700, a guide wire to facilitateplacement of the drainage device 100, 700, at least one dilator forexpanding an incision to facilitate placement of the drainage device100, 700, and a visualization device 1302 to facilitate placement of thedrainage device 100, 700. The visualization device 1302 may include, forexample, a fiber optic scope and/or a camera. The elements in thesurgical kit 1300 may provide complementary tools for a surgeon or otherpractitioner to use for draining a patient's body cavity. Each of theelements in the surgical kit 1300 or portions thereof may be sterilizedand otherwise prepared for use in surgery. In addition, one or more ofthe elements in the surgical kit 1300 may be provided at least partiallywithin a sterile envelope, protective covering, enclosure, or othercontainer within the surgical kit 1300 for additional protection fromcontamination or damage.

FIG. 14 illustrates an embodiment of a drainage device 1400 including anactivation apparatus 1412 and a detachable drainage tube 1402. Theactivation apparatus 1412 and detachable drainage tube 1402 may beconfigured to be detachably coupled together for positioning thedetachable drainage tube 1402 in a body cavity (e.g., for initialinsertion and/or for repositioning within the body cavity). Theactivation apparatus 1412 and detachable drainage tube 1402 may beselectively detached from each other, such as to provide increasedmobility to a patient. The detachable drainage tube 1402 may include atleast some similar features as the drainage tube 102 described above.For example, the detachable drainage tube 1402 may include a proximalend 1404, a distal end 1406, and one or more lateral openings 1410proximate the distal end 1406 of the detachable drainage tube 1402. Thedetachable drainage tube 1402 may also include elongated flexiblemembers 1408 extending from the proximal end 1404 to at or near thedistal end 1406 of the detachable drainage tube 1402, which may bedisposed within lumens longitudinally extending through a sidewall ofthe detachable drainage tube 1402.

The activation apparatus 1412 may include at least some similar featuresas the activation apparatus 112 described above. For example, theactivation apparatus 1412 may include a control device 1414, such as aknob or other element configured to be manually manipulated (e.g.,rotated) by a user to remotely move the distal end 1406 of thedetachable drainage tube 1402 when coupled thereto. The control device1414 may include a pinion configured to engage with first and secondracks 1416, 1418.

The proximal end 1404 of the detachable drainage tube 1402 may beconfigured to couple the detachable drainage tube 1402 to the activationapparatus 1412, and the activation apparatus 1412 may be configured tocouple with the detachable drainage tube 1402 in a complementaryfashion. Additionally, a linking element 1420 may be coupled to aproximal end of each of the elongated flexible members 1408 for operablyconnecting each of the elongated flexible members 1408 to a respectiveone of the first and second racks 1416, 1418. By way of example and notlimitation, each linking element 1420 may include a hook and each of thefirst and second racks 1416, 1418 may include a complementary slot orhook 1421. When operably connected, the hook of the linking element 1420may latch onto the complementary slot or hook 1421 of the respective oneof the first and second racks 1416, 1418. By way of another example, thelinking element 1420 may include a notch (e.g., an annular notch) andeach of the first and second racks 1416, 1418 may include acomplementary ridge or O-ring configured to deflect and snap into thenotch of the linking element 1420 when the detachable drainage tube 1402is operably connected to the activation apparatus 1412.

The activation apparatus 1412 may include a suction tube 1422 that maybe configured to form a fluid seal with a proximal end of the detachabledrainage tube 1402 when the detachable drainage tube 1402 is operablyconnected to the activation apparatus 1412. Accordingly, suction may beapplied to the suction tube 1422 to draw fluids from a body cavitythrough the detachable drainage tube 1402.

Accordingly, the drainage device 1400 may be used to withdraw fluidsfrom a body cavity of a patient by inserting the distal end 1406 of thedetachable drainage tube 1402 into the body cavity and, prior to orafter insertion of the distal end 1406 of the detachable drainage tube1402, operably coupling the activation apparatus 1412 to the proximalend 1404 of the detachable drainage tube 1402. To operably couple theactivation apparatus 1412 to the detachable drainage tube 1402, a fluidseal may be formed between the detachable drainage tube 1402 and thesuction tube 1422 and the linking elements 1420 may be coupled to thefirst and second racks 1416, 1418. When operably connected, theactivation apparatus 1412 may be used to remotely position the distalend 1406 of the detachable drainage tube 1402 within the body cavity.

The activation apparatus 1412 may also be detached from the detachabledrainage tube 1402, such as to enable increased patient mobility. Forexample, the linking elements 1420 may be decoupled from the first andsecond racks 1416, 1418, and the detachable drainage tube 1402 may bedecoupled from the suction tube 1422. In some embodiments, after theactivation apparatus 1412 is detached from the detachable drainage tube1402, the proximal end of the detachable drainage tube 1402 may becapped or plugged to inhibit fluid from inadvertently draining out ofthe detachable drainage tube 1402.

Referring to FIG. 14 in conjunction with FIG. 13, the surgical kit 1300may, in some embodiments, include the drainage device 1400 in a detachedor an attached configuration. In some embodiments, more than onedetachable drainage tube 1406, such as identical detachable drainagetubes 1406 or detachable drainage tubes 1406 of different lengths,diameters, materials, stiffnesses, etc., may be included in the surgicalkit 1300.

While the disclosure may be susceptible to various modifications andalternative forms, specific embodiments have been shown by way ofexample in the drawings and have been described in detail herein.However, it should be understood that the disclosure is not intended tobe limited to the particular forms disclosed. Additionally, embodimentsand features of the disclosure shown and/or described separately may becombined.

What is claimed is:
 1. A body cavity drainage device placement tool forplacing a body cavity drainage tube at least partially within a bodycavity of a patient, the body cavity drainage device placement toolcomprising: a shaft having a substantially circular cross-sectionalshape extending between a proximal end and a distal end of the shaft,the shaft comprising: a straight portion at the proximal end of theshaft; and a fixed curved portion at the distal end of the shaft, thefixed curved portion having a first diameter proximate to a transitionbetween the straight portion and the fixed curved portion and having asecond, smaller diameter at a distal end of the fixed curved portion,the distal end of the fixed curved portion defining the distal end ofthe shaft, wherein the shaft transitions from the first diameter to thesecond diameter at a shoulder and the second diameter of the shaft issmaller than an inside diameter of a ferrule coupled to a distal end ofthe body cavity drainage tube, and a projection of the ferrule extendsinto a central lumen of the body cavity drainage tube; and a handleattached to or integral with the proximal end of the shaft, wherein thedistal end of the shaft is sized and configured for insertion throughone lateral opening of a plurality of lateral openings proximate to adistal end of the body cavity drainage tube and at least partiallythrough the central lumen of the body cavity drainage tube and thesecond diameter of the shaft is configured to extend through the ferruleof the body cavity drainage tube, and wherein the body cavity drainagedevice placement tool stiffens the body cavity drainage tube such thatthe body cavity drainage tube is configured for insertion through anincision in the patient and into a pleural cavity without collapsing. 2.The body cavity drainage device placement tool of claim 1, wherein theshaft comprises a varying cross-sectional shape.
 3. The body cavitydrainage device placement tool of claim 2, wherein the shaft comprises afirst diameter at the proximal end and a second, different diameter atthe distal end.
 4. The body cavity drainage device placement tool ofclaim 3, wherein the first diameter is greater than the second diameter.5. The body cavity drainage device placement tool of claim 1, whereinthe shoulder is proximate the distal end of the shaft.
 6. The bodycavity drainage device placement tool of claim 5, wherein the shoulderis less than about one (1) inch (25.4 mm) from the distal end of theshaft.
 7. The body cavity drainage device placement tool of claim 1,wherein the shoulder of the shaft is configured to abut the ferrule whenthe distal end of the body cavity drainage device placement tool ispositioned proximate the distal end of the body cavity drainage tube. 8.The body cavity drainage device placement tool of claim 1, wherein theshoulder is proximate the proximal end of the shaft.
 9. The body cavitydrainage device placement tool of claim 8, wherein the shoulder isconfigured to abut a wall of the body cavity drainage tube surrounding alateral opening when the distal end of the body cavity drainage deviceplacement tool is proximate the distal end of the body cavity drainagetube.
 10. The body cavity drainage device placement tool of claim 1,wherein the shaft has a length sufficient to extend through one lateralopening of the plurality of lateral openings of the body cavity drainagetube and through the central lumen of the body cavity drainage tube andto position the distal end of the shaft beyond a distal end of the bodycavity drainage tube.
 11. The body cavity drainage device placement toolof claim 1, further comprising a channel extending through the shaft,wherein the channel is sized and configured to accommodate at least oneof a guide wire and an optical fiber, to facilitate placement of thebody cavity drainage device placement tool within the body cavity of thepatient.
 12. The body cavity drainage device placement tool of claim 1,wherein the body cavity drainage device placement tool has a modulus ofelasticity greater than a modulus of elasticity of the body cavitydrainage tube.
 13. A method of inserting a body cavity drainage deviceinto a body cavity of a patient, comprising: inserting a distal end of ashaft of a placement tool through one lateral opening of a plurality oflateral openings in a body cavity drainage tube proximate to a distalend of the body cavity drainage tube and into a central lumen of thebody cavity drainage tube, the shaft of the placement tool having asubstantially circular cross-sectional shape extending between aproximal end and the distal end of the shaft, the shaft comprising: astraight portion at the proximal end of the shaft; and a fixed curvedportion at the distal end of the shaft, the fixed curved portion havinga first diameter proximate to a transition between the straight portionand the fixed curved portion and having a second, smaller diameter at adistal end of the fixed curved portion, the distal end of the fixedcurved portion defining the distal end of the shaft, wherein the shafttransitions from the first diameter to the second diameter at a shoulderand the second diameter of the shaft is smaller than an inside diameterof a ferrule coupled to a distal end of the body cavity drainage tube,and a projection of the ferrule extends into the central lumen of thebody cavity drainage tube; abutting the shoulder of the shaft againstone of the body cavity drainage tube and the ferrule coupled to thedistal end of the body cavity drainage tube to position the distal endof the shaft of the placement tool and the second diameter of the shaftis configured to extend through the ferrule of the body cavity drainagetube; inserting the body cavity drainage tube and placement tool throughan incision in the patient and into the body cavity of the patientwherein inserting the body cavity drainage tube and placement toolthrough an incision in the patient and into the body cavity of thepatient comprises inserting the body cavity drainage tube and placementtool through an incision in the patient and into the pleural cavity ofthe patient without collapsing; and removing the placement tool from thebody cavity drainage tube and body cavity, wherein the body cavitydrainage tube remains in the body cavity in its inserted position as theplacement tool is removed from the body cavity drainage tube.
 14. Themethod of claim 13, wherein inserting a distal end of a shaft of aplacement tool through a lateral opening in a body cavity drainage tubecomprises inserting the distal end of the shaft of the placement toolthrough a lateral opening comprising at least one slit extending into awall of the body cavity drainage tube.
 15. The method of claim 13,wherein inserting a distal end of a shaft of a placement tool throughone lateral opening of a plurality of lateral openings in a body cavitydrainage tube comprises inserting the distal end of the shaft of theplacement tool through one lateral opening of the plurality of lateralopenings having a diameter greater than a diameter of another lateralopening of the plurality of lateral openings of the body cavity drainagetube.
 16. The method of claim 13, further comprising, after removing theplacement tool from the body cavity drainage tube and body cavity,positioning the body cavity drainage tube in a curved position in thebody cavity.